đź“‹ FDA Reference
Yoga Microcatheter
Codman & Shurtleff
Summary: The Yoga Microcatheter is a medical device used for accessing and navigating the venous system, primarily in interventional radiology. It is utilized by specialists for procedures involving venous stents.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K162563 ↗
Decision Date ?
January 5, 2017
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Yoga Microcatheter was cleared through the FDA 510(k) pathway on January 5, 2017, by Codman & Shurtleff. It is classified as a Class 2 medical device under product code DQY.
What It Is
The Yoga Microcatheter is a specialized catheter designed for use in the venous system. It is engineered to navigate complex vascular pathways, providing access for therapeutic interventions. Its flexible design allows for precise placement and delivery of stents or other devices in venous procedures.
FDA-Cleared Indications
- Percutaneous catheter access and navigation within the venous system.
- Use to support venous interventional procedures, including the placement of venous stents or other therapeutic devices.
Clinical Applications
- Venous access during image-guided endovascular procedures.
- Catheter navigation through complex venous anatomy.
- Support for delivery or placement of venous stents.
- Treatment procedures involving venous obstruction or narrowing when a venous intervention is indicated.
Practical Considerations
- The appropriate catheter size and configuration depend on the target vessel, anatomy, access route and device being delivered.
- Use requires compatible guidewires, introducer sheaths and, when applicable, stent-delivery systems.
- The catheter should be advanced under appropriate fluoroscopic or other intravascular imaging guidance by clinicians trained in endovascular procedures.
- MRI safety depends on the specific catheter configuration and labeling; verify the current product instructions before MRI exposure.
- As with other percutaneous vascular catheters, potential complications include bleeding, infection, vessel injury, thrombosis, embolization and contrast-related reactions.
Procedures that use this device
Frequently Asked Questions
What is the Yoga Microcatheter used for?
The Yoga Microcatheter is used for navigating the venous system and facilitating the placement of venous stents.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in procedures involving the venous system.
What are the FDA-cleared indications?
The device is indicated for use in the placement and navigation of venous stents, particularly in patients with venous obstructions or thrombosis.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.